Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

Learn more about:
Related Clinical Trial
Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms Intraoperative Fluorescence With Augmented Reality Clevidipine for Vasospasm After Subarachnoid Hemorrhage (SAH) Amnesia After Surgery for Anterior Communicating Aneurysm: High Resolution Magnetic Resonance (MR) Imaging Findings Hypothalamo-, Pituitary-, Adrenal Axis Dysfunction in Subarachnoid Hemorrhage The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms With Endovascular Therapy Esmolol Infusion in Patients Undergoing Craniotomy Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing. Registry for Study of Coils in Intracranial Aneurysms EEG Monitoring to Assess Emergence From Neuroanesthesia DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial Hydrogel Endovascular Aneurysm Treatment Trial Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial Remote Ischemic Preconditioning for Intracranial Aneurysm Treatment Doppler Flow Wires in Cerebral Angiography Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms Impact of Acute Cerebral Diseases on the Autonomous Nervous System: Progression and Correlation to Therapy and Outcome New Findings About Somatosensory Evoked Potentials (SEP) During Surgery for Cerebral Aneurysms Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity Use of Classic LMA During Endovascular Therapy HydroCoil Cerebral Aneurysm Treatment Trial Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 2 Decision Aids in Cerebral Aneurysm Treatment Framing Eighteen Coils in Cerebral Aneurysms Trial Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1

Brief Title

Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

Official Title

Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

Brief Summary

      The objective of this study is to explore the effects of Sirolimus on the underlying
      molecular alterations of cerebral aneurysms.

Study Phase

Phase 2

Study Type


Primary Outcome

Change in gene expression from control arteries.


Cerebral Aneurysm


Microsurgical clipping

Study Arms / Comparison Groups

 Microsurgical Clipping Treated with Sirolimus
Description:  Participants undergoing standard of care microsurgical clipping of unruptured cerebral aneurysm will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to surgery.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

December 1, 2020

Completion Date

December 1, 2025

Primary Completion Date

December 1, 2025

Eligibility Criteria

        Inclusion Criteria:

          1. Undergoing one of the following procedures at Jackson Memorial Hospital:

               -  Clipping of an unruptured cerebral artery aneurysm

               -  Endovascular treatment of unruptured cerebral aneurysms (including those
                  receiving coiling)

          2. ≥ 18 years of age

          3. Willing and able to give informed consent

        Exclusion Criteria:

        1) Subjects meeting any of the following criteria will be excluded:

          -  Dissecting, traumatic, or mycotic brain aneurysm.

          -  Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test.

          -  Women who are breastfeeding.

          -  Any clinically significant psychiatric or psychological disease, which would preclude
             the patient from completing the protocol.

          -  Patients with known Human Immunodeficiency Virus (HIV) infection or other known

          -  Patient with renal or liver failure

          -  Interstitial pneumonitis

          -  History of lymphoma

          -  History of skin cancer

          -  Hypersensitivity to sirolimus

          -  Severe or unstable concomitant condition disease or chronic condition, which in the
             opinion of the investigator could affect assessment of the safety or efficacy of study




18 Years - N/A

Accepts Healthy Volunteers



Robert M Starke, M.D., 305-243-3806, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party

Principal Investigator

Study Sponsor

University of Miami


 National Institute of Neurological Disorders and Stroke (NINDS)

Study Sponsor

Robert M Starke, M.D., Principal Investigator, University of Miami

Verification Date

September 2020